FDA UDI
In Commercial Distribution
🇺🇸 United States
HealthView ECG Manager
DI: 00857560008010
·
Model: 1.2.5
·
LUMEDX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HealthView ECG Manager
- Primary DI
- 00857560008010
- Version / Model
- 1.2.5
- Catalog Number
- 113-01003
- Company Name
- LUMEDX CORPORATION
- Labeler DUNS
- 625427471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-30
- Public Version
- 5
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- 2cfe59a1-a2a0-4af7-83ba-4430849c3894
Device Description
The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44098 | Cardiology information system application software | An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857560008010 | GS1 |